An accurate, precise, sensitive, and rapid isocratic reversed phase high-performance liquid chromatographic (RP-HPLC) method for the analysis of olanzapine (OLP) in bulk drug and in tablets has been developed and validated. Analysis was performed on a 150？mm × 4.6？mm, 5？μm particle Intersil ODS 3V column with 10？mM disodium hydrogen phosphate buffer (pH 7.4)-acetonitrile (35？:？65) (v/v) as mobile phase at a flow rate of 1.0？mL？min？1 with UV detection at 254？nm; the constant column temperature was 40°C. The runtime under these chromatographic conditions was less than 8？min. The calibration plot was linear over the concentration range of 2.5–20.0？μg？mL？1 with limits of detection and quantification values of 50 and 200？ng？mL？1, respectively. The precision and accuracy of the method were assessed by determination of validation data for precision (intraday RSD values of 0.11–0.28%, interday RSD values of 0.15–0.46%), accuracy (0.87–2.80% intraday, 0.33–1.80% interday), and specificity, in accordance with the ICH guidelines. The stability of standard solution and tablet extract was also studied over a period of 24？h. The method was applied for the determination of OLP in tablets with satisfactory results. 1. Introduction Olanzapine (OLP), chemically known as 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno-[ ][ ] benzodiazepine (Figure 1), is the most commonly prescribed second generation neuroleptic agent for the treatment of schizophrenia and other psychotic disorders. Figure 1: Structure of OLP. A complete literature survey of analytical methods for OLP is done. Titrimetry [1–3], visible spectrophotometry [2, 4–10], kinetic spectrophotometry [11], UV-spectrophotometry [1, 12], and capillary zone electrophoresis and linear voltammetry [12] have been reported for the quantification of OLP in pharmaceuticals. High-performance thin layer chromatography (HPTLC) has been used to quantify OLP in pharmaceuticals [13–15]. Several liquid chromatographic methods have also been reported for the assay of OLP in pharmaceuticals and/or biological materials. High performance liquid chromatography (HPLC) with UV-detection has been applied for the determination of the drug in human blood serum [16–18] and blood plasma [19–21]. The drug in blood plasma/whole blood has also been assayed by HPLC with amperometric [22, 23], coulometric [24], and MS [25, 26] detection. OLP in rat brain is reported to have been determined by HPLC with coulometric detection [27] whereas for its assay in breast milk [28], the same technique with electrochemical detection has been employed. HPLC with
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